ManagerSr ManagerAGM QA
ManagerSr ManagerAGM QA
Posted on :
28-02-2025
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1 Vacancy
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Job Description
Department: Quality Assurance
Reports To: Global Manager Quality & Compliance
Location: Jhagadia Gujarat India
Educational Qualification: M.Sc Chemistry desirable
Experience (in years): 15 Years minimum with exposure FDA audits for APIs
Purpose of the Role:
Accountable for quality of the product and processes by establishing and enforcing quality management systems; validating processes; striving to meet customer requirements and achieving Audit compliance
Key Responsibility Areas:
- Establish quality and reliability by adhering to procedures conforming product requirement customer needs in accordance to Good Manufacturing Practices and regulatory requirements
- Responsible for implementation of Quality Management system across all functions through awareness training and monitoring and ensure preparedness of site for any surprise US FDA and FDCA Audits
- Develop quality assurance plans by conducting risk analyses; identifying critical control points monitoring processes and implement corrective actions based on investigation findings.
- Ensure QMS activities like Change control OOS/OOT Internal Audits Vendor Qualification Equipment Qualifications (including Computer Validations) are followed in accordance with implemented SOPs and deviations are recorded and investigated.
- Ensure that site remains in the state of Certification. Recertification audits should not result in major or critical nonconformances (EFfCI ISO 9001:2015/ Hala/ SIRIM and NSF certifications)
- Conduct Annual Quality reviews for measuring the performance of the process and escalate critical observations to Senior management
- Assuring Quality of the product for its conformity to customer specifications before releasing it for distribution
- Lead all customer related responses from site and communicate effectively to meet site requirements.
- Ensure that customer complaints are timely investigated and closed through CFT review and assessment with identification of proper CAPA plan. Monitoring effectiveness of CAPA plan is desirable.
- Conduct and drive Periodic Training on QMS aspects to create better awareness and ensure that knowledge is applied at shop floor by employee.
- Ensures that personnel performing conformance to product requirements are competent on the basis of appropriate education training skills and experience.
- Liase with Regulatory Affairs & Sales team as needed to meet changes in regulations specification and other areas based on changes in Pharmacopeias Regulations and customer needs.
- Ensure that License requirements of site are met and there are no major findings during inspections/ audits at site
- Ensure that staff are adequately trained mentored as needed to perform the job effectively. Empower team for decision making and carry out proper investigations of repeated failure to prevent REwork and enhance efficiency at work.
- Ensure that External warehouses compliances are monitored and managed through proper risk assessment to ensure the correct product delivery following FEFO/ FIFO as applicable.
- Update SMF Policies and Manuals to keep them current and meeting the organizational regulatory and customer requirements. Ensure that changes at site are discussed communicated to Regulatory functions to comply with the Site Plan as shared with FDCA.
- Work with Project R&D and operations to ensure that third party manufacturing adheres to Quality Protocol and meets customer requirements.
- Liase with other sites as needed and support with any gap assessment needed for enhancement of customer satisfaction or Quality Management System.
- Perform the task delegated by the Management for any other roles and responsibilities either due to current or future business needs.
- Demonstrate leadership to keep the team motivated and align them to meet organizational requirements by prioritizing the tasks
Essential Skills:
- Customer Focus
- Team Working Ability
- Initiatives
- Leadership Skills
- Communication (verbal oral and written)
Employment Type
Full Time
Key Skills
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